Drugplain

nasal .05 g/100mL

Oxymetazoline hydrochloride · SPRAY · Rite Aid Corporation

10 Recalls on Record
Plain English

Oxymetazoline hydrochloride nasal spray is a decongestant used to temporarily relieve nasal congestion due to colds, allergies, or sinus problems. It works by narrowing blood vessels in the nasal passages to reduce swelling and improve airflow.

Key Facts

Brand Name
nasal
Generic Name
Oxymetazoline hydrochloride
NDC Code (Product)
11822-6623
Manufacturer
Rite Aid Corporation
Strength
.05 g/100mL
Dosage Form
SPRAY
Route
NASAL
Marketing Status
Application #
M012
Marketing Start
12/05/2018

Recall History

10 Recalls on Record
Class II10/26/2021

Perrigo Company PLC

CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

TerminatedVoluntary: Firm initiated
Class II01/30/2013

TG United, Inc.

CGMP Deviations: Products are underdosed or have an incorrect dosage regime.

TerminatedVoluntary: Firm initiated
Class II08/03/2018

Product Quest Manufacturing LLC

CGMP Deviations: products manufactured under conditions that could impact its product quality.

TerminatedVoluntary: Firm initiated
Class II02/27/2015

Akorn, Inc.

Failed Stability Specifications: Out of specification for preservative, benazalkonium chloride.

TerminatedVoluntary: Firm initiated
Class II01/30/2013

TG United, Inc.

CGMP Deviations: Products are underdosed or have an incorrect dosage regime.

TerminatedVoluntary: Firm initiated
Class II10/26/2021

Perrigo Company PLC

CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

TerminatedVoluntary: Firm initiated
Class II05/21/2019

Torrent Pharma Inc

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

TerminatedVoluntary: Firm initiated
Class I12/12/2025

Medinatura New Mexico, inc.

Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter.

OngoingVoluntary: Firm initiated
Class III02/05/2018

Sun Pharmaceutical Industries, Inc.

Sun Pharmaceutical is recalling Azelastine HCl Nasal Solution, 0.1% (30 mL Bottle) following a failure to meet the % RSD requirement in the test for Droplet Size during the 6 month long term stability test station

TerminatedVoluntary: Firm initiated
Class II08/03/2018

Product Quest Manufacturing LLC

CGMP Deviations: products manufactured under conditions that could impact its product quality.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective15,570 reports
off label use14,162 reports
fatigue13,869 reports
pain12,570 reports
nausea11,663 reports
headache11,258 reports
dyspnoea10,933 reports
rash10,050 reports
vomiting9,026 reports
diarrhoea8,933 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses temporarily relieves sinus congestion and pressure temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies

Dosage & Administration

Directions adults and children 12 years and over: take 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours. children under 12 years: ask a doctor

Warnings

Warnings Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have heart disease diabetes thyroid disease high blood pressure difficulty in urination due to enlargement of the prostate gland When using this product do not exceed recommended dosage. Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur symptoms do not improve within 7 days or occur with fever If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Frequently Asked Questions

What is nasal used for?

Oxymetazoline hydrochloride nasal spray is a decongestant used to temporarily relieve nasal congestion due to colds, allergies, or sinus problems. It works by narrowing blood vessels in the nasal passages to reduce swelling and improve airflow.

Is nasal a controlled substance?

nasal is not classified as a controlled substance by the DEA.

What is the generic name for nasal?

The generic name for nasal is Oxymetazoline hydrochloride. There are 12 other brand versions of Oxymetazoline hydrochloride.

What is the NDC code for nasal .05 g/100mL?

The NDC (National Drug Code) for nasal .05 g/100mL is 11822-6623, listed by Rite Aid Corporation.